Alzheimer DiseasePhase 4NCT03168997
Memantine Treatment in Alzheimer's Disease Patients
A Phase 4 study testing Memantine Hydrochloride in people with Alzheimer Disease, run by Wei Cuibai.
Trial summary
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Memantine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2017to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
- Male or female, 50 years and older ;
- All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
- Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
- Provide the informed consent.
Who cannot join
- Patients with disturbance of consciousness of any causes;
- Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
- Patients with mental illness;
- Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
- Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
- Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
- Subjects who are unwilling or unable to abide by the study requirement.
About this study
Official title: Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD
Read the detailed description
Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.
- Conditions
- Alzheimer Disease
- Being tested
- Memantine Hydrochloride
- Keywords
- Alzheimer Disease Memantine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine HydrochlorideDrug
Also called Memantine
Memantine Hydrochloride treatment according to clinical routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Mild AD | Other | Memantine Hydrochloride 20mg tablet per day by mouth on mild AD Receives: Drug: Memantine Hydrochloride |
| Moderate AD | Other | Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD Receives: Drug: Memantine Hydrochloride |
| Severe AD | Other | Memantine Hydrochloride 20mg tablet per day by mouth on severe AD Receives: Drug: Memantine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog change
Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale
Measured: ADAD-cog Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Jul 2017 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Cuibai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Cuibai, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168997
- Sponsor's protocol ID
- 17237T
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT03168997
- Acronym / sponsor ID
- 17237T
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease Memantine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Wei CuibaiUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD
Detailed description
Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild AD | Other | Drug: Memantine HydrochlorideMemantine Hydrochloride 20mg tablet per day by mouth on mild AD |
| Moderate AD | Other | Drug: Memantine HydrochlorideMemantine Hydrochloride 20mg tablet per day by mouth on moderate AD |
| Severe AD | Other | Drug: Memantine HydrochlorideMemantine Hydrochloride 20mg tablet per day by mouth on severe AD |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
- Male or female, 50 years and older ;
- All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
- Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
- Provide the informed consent.
Key exclusion criteria (7 listed)
- Patients with disturbance of consciousness of any causes;
- Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
- Patients with mental illness;
- Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
- Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine HydrochlorideAlso: MemantineMemantine Hydrochloride treatment according to clinical routine treatment | Drug | Mild AD, Moderate AD, Severe AD |
Primary outcome
ADAS-cog change
Time frame: ADAD-cog Change from baseline to 24 weeks
Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine Hydrochloride in people with Alzheimer Disease, run by Wei Cuibai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog change (time frame: ADAD-cog Change from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.